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Roche Diagnostics
cobas
®
pulse · Software version 01.03 · User Assistance · Publication version 1.0
Feedback
Every effort has been made to ensure that this
publication fulfills the intended use. All feedback on any
aspect of this publication is welcome and is considered
during updates. Contact your Roche representative,
should you have any such feedback.
Approvals
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®
pulse meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog global website
(dialogportal.roche.com) and choose the eLabDoc link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
Compliance with the applicable directives is provided by
means of the declaration of conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
The system fulfills the Canadian and U.S. safety
requirements (UL LISTED, in accordance with UL
61010-1 and CAN/CSA-C22.2 No. 61010-1).
This device contains license-exempt transmitter(s)/
receiver(s) that comply with Innovation, Science and
Economic Development Canada’s license-exempt
RSS(s), and complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference
2. This device must accept any interference received,
including interference that may cause undesired
operation of the device.
FIPS
PLACEHOLDER
Validated under Federal Information Processing
Standard (FIPS) 140-3, Security Requirements for
Cryptographic Modules.
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